Consultation: Product Information as a package insert - consumer administered injectables

Overview

Product Information (PI) as a package insert in non-HCP injectable products

The Therapeutic Goods Administration (TGA) is seeking feedback on the current usage of paper information included with injectable medicines. This consultation aims to understand whether the paper copy of the Product Information (PI) document is helpful for patients and carers when it is included in the packaging of injectable medicines that they administer themselves.

What is a PI?

The Product Information is a document has been written by the pharmaceutical company responsible for the medicine and has been approved by the TGA. The PI typically ranges between 10-35 pages.

Injections which are administered by patients or carers must contain the Product Information as a pack insert. It can be identified by the words ‘Australian Product Information’ at the beginning of the document. Please note the following survey questions relate to the Product Information (PI) only, and do not relate to any other leaflets that may be present in injection packaging (such as instruction leaflets or Consumer Medicines Information leaflets).

Why is the TGA consulting about the removal of the PI for injectable products?

In 2023, the TGA made a decision to remove the PI from some health-care professional (HCP) administered injectables based on the results of a public consultation.

The TGA is now seeking input from patients and support groups as to whether the PI is beneficial in injectable products administered by patients and carers, and supports safe and effective use.

Why your views matter

The TGA is now investigating whether the PI is valuable to patients and/or carers who give injections and would like your feedback. Some factors which are being considered are:

• The PI is a document intended for HCPs
• Currently, the physical PI package insert may be missing any recently added important safety information
• There are environmental impacts associated with the inclusion of the PI as a hard copy

You can find details about this consultation in the Consultation Paper under 'Related' below.